Umbilical Hernia
Conditions
Keywords
Umbilical Hernia
Brief summary
The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery. This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.
Interventions
PROCEDUREIntraperitoneal mesh placement
Mesh placement inside the peritoneal cavity.
PROCEDUREPreperitoneal mesh placement
Mesh placement between peritoneum and muscle layer.
Sponsors
Medri
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* written informed consent from the patient or his/her legal representative * primary umbilical hernia requiring elective surgical repair * diameter between 0 and 3 cm
Exclusion criteria
* no written informed consent * incisional hernia at the level of the umbilicus * recurrent umbilical hernia, as they have to be considered an incisional hernia * emergency surgery (incarcerated hernia) * pregnancy * non-compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement. | Total duration of the operation with an expected average of approximately 45 minutes. | Time registration of the operating time will be extracted from the hospital electronic patient files. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical wound morbidity complication rate. | Up to 1 year. | — |
| Recurrence Rate | up to 2 years | Clinical examination will be performed. No ultrasound, unless doubt about recurrence. |
| Pain evaluation | within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years | A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has pain. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score. |
| Discomfort evaluation. | Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years. | A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has discomfort. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score. |
Countries
Belgium
Outcome results
None listed